A better heart-valve fix
The minimally invasive procedure called TAVR gets patients feeling chipper faster.
To get blood to the rest of your body, your heart pumps it into the aorta, the main artery, through a valve that opens and closes, maintaining blood flow in the right direction. As you age, calcium deposits may cause that valve to become stiff and inflexible—to the point where eventually it doesn’t open fully. This is called aortic stenosis, and it can cause a decrease in blood flow from the heart. Left untreated, it can lead to heart attack, stroke and death.
Until the past few years, the only way to repair an impaired aortic artery was with open-heart surgery. Those procedures were very successful for otherwise healthy individuals, but since aortic stenosis tends to afflict older patients who also have other health concerns, the operation was more than many people could handle. For them, there was no reliable treatment. Since 2012, however, high-risk patients have been able to take advantage of a minimally invasive procedure called trans-aortic valve replacement surgery, or TAVR. And in April, Saint Barnabas Medical Center opened a new operating room specifically designed to accommodate this cutting-edge surgery and offer it to patients.
TAVR works in a fashion similar to the way interventional cardiologists insert a stent into a blocked artery, TAVR involves threading a catheter through an artery in the groin—or occasionally through an artery in the chest—to the heart. Instead of removing the old, damaged valve, which is the approach used in open-heart repair, TAVR squeezes a collapsed replacement valve into the damaged valve’s place. The new valve is then expanded to push the old valve to the sides and regulate blood flow.
Cardiac surgeon Mark Russo, M.D., director of the Aortic Center at Saint Barnabas, says the benefits are significant. “With open-heart surgery, you need to use a heart-lung machine, the operation takes two hours and the patient is in the hospital five to seven days with a recovery period of six to eight weeks,” he says. “With TAVR, we don’t stop the heart, we don’t cut out the old valve, the procedure takes about 30 minutes and patients go home the next day or the day after. Most patients feel better when they wake up and are back to normal activities within a week.”
More than that, TAVR reduces the risk of death within 30 days from aortic stenosis by 75 percent in these high-risk patients, who are not healthy to begin with. “This therapy prolongs survival and increases functional status, and it makes older people feel better,” Dr. Russo says.
The new operating room where TAVR will take place is called a hybrid OR, because the procedure requires the skills—and the tools—of both a cardiac surgeon and an interventional cardiologist. On some rare occasions, the TAVR procedure may need to be aborted and open-heart surgery performed instead. The hybrid OR is ready for both methodologies. “It’s a collaboration between me and Dr. Russo,” says Bruce Haik, M.D, an interventional cardiologist who is system director of the cardiac catheterization labs for Barnabas Health System. The team also includes cardiac imaging specialists to monitor the procedure as it happens in real time and in three dimensions.
TAVR has been so successful in helping high-risk patients, it is now being studied as an alternative for those with moderate risk as well—and the early results are promising there too. For those at intermediate risk, 30-day mortality rates are reduced by 80 percent. “These are overwhelmingly good outcomes,” Dr. Russo says. Eventually, he believes, TAVR is likely to be approved for all patients.
A toast to TAVR!
Usually doctors don’t like to make predictions, but when it comes to the procedure called TAVR—trans-aortic valve replacement (see main article)—Saint Barnabas Medical Center clinicians are boldly bullish.
“I think within five years it will displace open-heart surgery as the gold standard of care for treating aortic stenosis,” says Mark Russo, M.D., director of Saint Barnabas’ Aortic Center.
Interventional cardiologist Bruce Haik, M.D, agrees. “Until recently, the question was, ‘Who should have TAVR?’” says Dr. Halik, who is director of the Barnabas Health system’s cardiac catheterization labs. “Now it’s, ‘Why would you send someone for an open-heart operation?’”
Dr. Haik and his colleagues at New Jersey Cardiology Associates would know. They recently celebrated their patients’ 500th TAVR procedure. A party was held to mark this milestone, and several patients came—including an 83-year-old man who’d had the procedure just a week earlier.
“He was having a Scotch with us,” Dr. Haik says with a laugh.
About aortic stenosis
Aortic stenosis—a narrowing of the aortic valve opening—occurs in about 2 percent of people over 65 years of age. It is found more often in men than in women. Most people with aortic stenosis do not develop symptoms until the condition is advanced. The diagnosis may be made when a clinician hears a heart murmur and performs tests.
Symptoms of aortic stenosis include:
• Chest discomfort: The chest pain may get worse with activity and reach into the arm, neck, or jaw. The chest may also feel tight or squeezed.
• Cough, possibly bloody
• Breathing problems when exercising
• Becoming tired easily
• Feeling the heart beat (palpitations)
• Fainting, weakness, or dizziness with activity
Source: National Institutes of Health
Please call us at (732) 235-7231 or send an email here.
For your convenience, Telemedicine Consults are available for patients. To schedule a consultation, please call 732-235-7231.
Minimally invasive valve surgery is a specialized approach to treating heart valve disease that avoids the need to “crack the chest.” This method uses sophisticated instruments to perform the surgery through a smaller incision at the side of the chest and offers the patients less pain and faster recovery. We perform nearly all of our isolated valve surgeries minimally invasively.
An aortic aneurysm is a bulging, weakened area in the wall of main blood vessel in the body. The risk of aortic catastrophe, including dissection and rupture, increases dramatically with an aneurysm. Surgery may be recommended when the aorta is larger than 4.5-6 cms. Factors including family history, lifestyle, and need for other heart surgery guide decisions about surgery.
Transcatheter aortic valve replacement (TAVR), also known as transcatheter aortic valve implantation (TAVI), is a minimally invasive approach to the treatment of aortic stenosis. In most patients, it requires no incision and typically patients are discharged within 1 day. Dr Russo is among the most experienced TAVR surgeons in the US.
A “bypass” or “cabg” surgery is the most commonly performed heart surgery. It is necessary when the coronary arteries, which provide blood to the heart become narrow preventing sufficient blood from passing through, and thus depriving the heart of oxygen and nutrients. RWJUH has CABG outcomes that exceed national benchmarks.
When other treatments are insufficient, a heart transplant is a surgical procedure offered to patients with the most severe damage to the heart. RWJUH is one of a limited number of centers in the US that offer advance heart failure surgery, including heart transplant. Dr. Russo has participated in 500+ successful transplant surgeries.
The MitraClip device is a small clip that helps your mitral valve to close more completely. The procedure does not require opening the chest or stopping the heart. Instead, through a vein in the leg, a thin tube (called a catheter) is guided to the mitral valve. Dr. Russo is among the highest volume Mitraclip operators in the Northeast.
Transcatheter aortic valve replacement vs OMM (randomized) for asymptomatic severe AS The EARLY TAVR trial (Edwards) looks at transcatheter aortic valve replacement (TAVR) as an effective treatment for patients with asymptomatic aortic stenosis. Patients are randomized to either treatment with TAVR or clinical surveillance until the develop symptoms, at which point they are eligible to be treated with TAVR. Read More
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve in subjects with moderate, calcific aortic stenosis. Patients are randomized to S3 TAVR device or medical management. Read More
ALIGN-AR evaluates the safety and probable benefit of the transfemoral JenaValve Pericardial TAVR System in patients with symptomatic severe aortic regurgitation. Patients who are high risk for open surgical aortic valve replacement/repair are eligible. RWJUH is one of only 15 centers in the U.S. that can offer this therapy that has been granted a “Breakthrough Device Designation” by the US Food and Drug Administration. This designation is reserved for investigative therapies designed to treat a serious or life-threatening disease or condition and where preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
Transcatheter aortic valve replacement for severe AS with a novel deviceEvaluates the safety and efficacy of Acurate (Boston Scientific) valve for transcatheter aortic valve replacement. For patients with severe aortic stenosis who are at intermediate or greater risk for SAVR. Patients are randomized to Acurate or commerical TAVR device. Read More
The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable.
The SUMMIT-Tendyne trial (Abbott) evaluates the safety and effectiveness of using the Tendyne Mitral Valve System for the treatment of symptomatic mitral regurgitation or mitral annular calcification in patients who are not appropriate for conventional mitral valve surgery. In the randomized arm, patients are treated with either the Tendyne device or MitraClip, while patients in the non-randomized and MAC arms receive the Tendyne device. https://clinicaltrials.gov/ct2/show/NCT03433274
CLASP IID/F is a prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair in patients with degenerative/functional mitral regurgitation with the Edwards PASCAL Transcatheter Valve Repair System compared with the commercially available device (Abbott MitraClip).
RESTORE is a prospective, multicenter, non-randomized trial designed to evaluate the safety and effectiveness of the HARPOON™ Beating Heart Mitral Valve Repair System in patients with severe degenerative mitral regurgitation (DMR).